Trial Outcomes & Findings for Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients (NCT NCT00824993)
NCT ID: NCT00824993
Last Updated: 2018-09-13
Results Overview
The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
78 participants
Primary outcome timeframe
Baseline to 6 months and Baseline to 12 months
Results posted on
2018-09-13
Participant Flow
This was a prospective, randomized, placebo-controlled trial. Eligible patients were at least 18 years old and had undergone an allo-SCT for hematologic malignancy treatment within 45 days.
We screened 414 patients and 78 were enrolled.
Participant milestones
| Measure |
Ibandronate
One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
Control
Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
6 Month Follow up
|
33
|
27
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
Reasons for withdrawal
| Measure |
Ibandronate
One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
Control
Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Malignancy Relapse
|
9
|
10
|
|
Overall Study
Rapid Bone Loss
|
0
|
1
|
|
Overall Study
Non-Compliant
|
2
|
1
|
|
Overall Study
Insurance Issue
|
2
|
1
|
|
Overall Study
Death
|
0
|
3
|
Baseline Characteristics
Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients
Baseline characteristics by cohort
| Measure |
Ibandronate
n=39 Participants
One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
Control
n=39 Participants
Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
53 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months and Baseline to 12 monthsPopulation: We analyzed changes in BMD from baseline only for those who had follow up BMD evaluated at 6 and 12 months
The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline.
Outcome measures
| Measure |
Ibandronate
n=39 Participants
One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
Control
n=39 Participants
Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
|---|---|---|
|
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
% change baseline to 12m, FN
|
-4.29 Percentage change
Standard Deviation 5.71
|
-5.2 Percentage change
Standard Deviation 5.25
|
|
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
% change baseline to 6m, LS
|
0.06 Percentage change
Standard Deviation 4.03
|
-2.61 Percentage change
Standard Deviation 4.2
|
|
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
% change baseline to 6m, FN
|
-3.63 Percentage change
Standard Deviation 4.18
|
-4.85 Percentage change
Standard Deviation 5.37
|
|
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
% change baseline to 6m, TH
|
-2.73 Percentage change
Standard Deviation 3.88
|
-4.72 Percentage change
Standard Deviation 4.32
|
|
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
% change baseline to 12m, LS
|
1.27 Percentage change
Standard Deviation 5.29
|
-1.81 Percentage change
Standard Deviation 4.49
|
|
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
% change baseline to 12, TH
|
-4.85 Percentage change
Standard Deviation 5.47
|
-5.68 Percentage change
Standard Deviation 5.15
|
Adverse Events
Ibandronate
Serious events: 0 serious events
Other events: 21 other events
Deaths: 1 deaths
Control
Serious events: 0 serious events
Other events: 24 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ibandronate
n=39 participants at risk
One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
Control
n=39 participants at risk
Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
|
|---|---|---|
|
Infections and infestations
Infection - Other (Bacteremia)
|
0.00%
0/39 • Baseline to 12 months
|
5.1%
2/39 • Baseline to 12 months
|
|
Infections and infestations
Infection
|
15.4%
6/39 • Baseline to 12 months
|
10.3%
4/39 • Baseline to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
5.1%
2/39 • Baseline to 12 months
|
5.1%
2/39 • Baseline to 12 months
|
|
Gastrointestinal disorders
GI GVHD
|
0.00%
0/39 • Baseline to 12 months
|
10.3%
4/39 • Baseline to 12 months
|
|
Renal and urinary disorders
Cystitis
|
2.6%
1/39 • Baseline to 12 months
|
7.7%
3/39 • Baseline to 12 months
|
|
General disorders
Fever
|
2.6%
1/39 • Baseline to 12 months
|
5.1%
2/39 • Baseline to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.6%
1/39 • Baseline to 12 months
|
5.1%
2/39 • Baseline to 12 months
|
|
Metabolism and nutrition disorders
Other
|
25.6%
10/39 • Baseline to 12 months
|
12.8%
5/39 • Baseline to 12 months
|
Additional Information
Lu,Huifang,M.D. PH.D. / General Internal Medicine
UT MD Anderson Cancer Center
Phone: 713-563-4462
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place